ViiV Healthcare's Dovato (dolutegravir/lamivudine) has shown comparable efficacy to a three-drug regimen in achieving viral suppression in adult patients with advanced HIV. The findings come from a post-hoc analysis of the 48-week results of the DOLCE study, a multicenter, randomized, open-label trial involving approximately 230 antiretroviral treatment-naïve individuals with advanced HIV, characterized by low CD4 counts.
The DOLCE study randomized participants in a 2:1 ratio to receive either Dovato or a three-drug regimen (DTG+TDF/XTC). The primary endpoint was the proportion of subjects with a viral load of less than 50 copies/ml at week 48. In the Dovato arm, 82% of individuals achieved viral suppression, compared to 80% in the three-drug regimen arm.
Efficacy was comparable between both treatment arms, including among those with a baseline viral load greater than 500,000 copies/ml. The safety profiles were also similar, with comparable rates of serious adverse events and immune reconstitution inflammatory syndrome.
Implications for HIV Treatment
The current landscape of HIV treatment often involves multi-drug regimens, which can lead to increased pill burden and potential for adverse effects. Dovato offers a simplified, two-drug approach, which may improve adherence and quality of life for patients. These findings suggest that Dovato can be a viable option for treatment-naïve adults with advanced HIV, even those with low CD4 counts and high viral loads.
Expert Commentary
"We know taking fewer medicines is an important consideration for many in the HIV community, and these new data continue to reinforce the efficacy and safety of Dovato, a two-drug regimen," said Harmony Garges, chief medical officer at ViiV Healthcare. "The findings from the DOLCE study build on the robust body of evidence supporting its use in treatment-naive adults living with HIV and shows comparable efficacy to a three-drug regimen, even in people with low CD4 counts and high viral loads."
